SOP-013 · Sampling, QC and release
In-process and finished-product checks before supply.
Template for local scientific review and approval. This is not an approved SOP of a specific laboratory.
SOP-013 · 1.0 · 10.09.2026
Scope
In-process and finished-product checks before supply.
Roles and prerequisites
Responsible pharmacist: approves implementation and release. Trained operator: performs and records work. Reviewer: verifies critical items. Specialist clinician/analytical partner: as specified.
Before implementation complete local document IDs, named roles, suitable equipment, specific specifications and acceptance criteria. Check the applicable framework in your country.
Procedure
Before the batch define critical attributes, method, samples, limits and responsibilities. Do not set retrospective limits to fit results.
Design sampling representative of location, time and container. Maintain sample identity and transport conditions.
Record actual results, units, instrument and raw data. An “OK” entry alone is inadequate for a quantitative test.
Link external analysis to the exact batch and method. Assess laboratory and method suitability for the specific matrix.
Investigate an out-of-specification result before repeating. Do not test repeatedly to select only a passing result.
The authorised pharmacist reviews the record, deviations, label, QC and BUD together. Record release, quarantine or rejection with reasons.
Stop criterion
Pending critical testing or unresolved OOS: quarantine, not provisional release.
Related records
Sources
- NAPRA — Model Standards for Pharmacy Compounding of Non-sterile Preparations (2018; clarification 2022)
- NAPRA — Guidance Document for Non-sterile Preparations
These sources inform the original editorial synthesis. Their publishers do not adopt or endorse this SOP.
Local approval
Local version: __________ Effective date: __________
Author: __________ Reviewer: __________ Pharmacist approval: __________
Signatures / dates: __________ Next review: __________